Spiriva Respimat Gains Indication and New Dosage Strength

New indication and dosage strength
New indication and dosage strength

Boehringer Ingelheim announced that Spiriva Respimat (tiotropium bromide) is now available for the long-term maintenance treatment of asthma in patients ages ≥12 years. 

Spiriva Respimat is a long-acting muscarinic antagonist (LAMA), making it the first new class of inhalation agents approved for asthma in over 10 years. Spiriva Respimat is steroid-free and has a different mechanism of action than a long-acting beta-2 agonist (LABA). Tiotropium has similar affinity to the subtypes of muscarinic receptors, M1 to M5. In the airways, it exhibits pharmacological effects through inhibition of M3-receptors at the smooth muscle leading to bronchodilation.

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The expanded approval for Spiriva Respimat was based on efficacy and safety data from a comprehensive clinical trial program, which included 12 trials of approximately 5,000 patients with mild, moderate, and severe symptomatic asthma on at least an inhaled corticosteroid (ICS) or ICS/LABA.

Spiriva Respimat is already indicated for the the long-term maintenance treatment of bronchospasm due to chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema—to reduce exacerbations of COPD. The 1.25mcg/actuation strength is intended for this new indication.

It is available as 1.25mcg/actuation and 2.5mcg/actuation dosage strengths containing a total of 60 metered actuations. Spiriva Respimat is supplied in a carton containing one Spiriva Respimat cartridge and one inhaler.

For more information call (800) 542-6257 or visit Spiriva.com.